A Safety and Tolerability Study of Nitazoxanide in HIV-HCV Treatment Failures

This study has been completed.

Sponsor:

National Institutes of Health Clinical Center (CC)

ClinicalTrials.gov Identifier:

NCT01185028

First Posted: August 19, 2010

Last Update Posted: May 27, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Nitazoxanide With Pegylated Interferon And Ribavirin

Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks

Baseline Measures

Nitazoxanide With Pegylated Interferon And Ribavirin

Overall Participants Analyzed [Units: Participants]

8

Age [Units: Participants]

<=18 years

0

Between 18 and 65 years

7

>=65 years

1

Age [1] [Units: Years]Mean (Standard Deviation)

56.375 (7.4487834577198)

[1]

Mean has been calculated to the third decimal place. Standard Deviation value has been calculated to the thirteenth decimal place

Adverse events determined and evaluated by patient reporting and the DAIDS toxicity table.

Time Frame

2 years

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Nitazoxanide With Pegylated Interferon And Ribavirin

Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks

Measured Values

Nitazoxanide With Pegylated Interferon And Ribavirin

Participants Analyzed [Units: Participants]

8

Number of Participants With Adverse Events [Units: Adverse events]

8

No statistical analysis provided for Number of Participants With Adverse Events